NCT01190696

Brief Summary

The purpose of this study is to determine which method is better for treatment of femoral fracture in children in outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2010

Completed
Last Updated

August 30, 2010

Status Verified

February 1, 2009

Enrollment Period

11 months

First QC Date

August 27, 2010

Last Update Submit

August 27, 2010

Conditions

Femoral Shaft Fracture

Keywords

Spica CastTENFemoral Shaft FractureChildren

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    identification of Length of hospital stay (days)for patients who treated with titanium elastic nailing or casting

    at 1 months post-operatively

Secondary Outcomes (3)

  • the time to walking with aids

    at 1 months post-operatively

  • parent's satisfaction

    at 1 months post-operatively

  • the time absent from school

    at 1 months post-operatively

Study Arms (2)

hip spica casting

OTHER

Patients in the spica cast group treated with skeletal traction and spica cast applied for them

Device: Hip spica casting

titanium elasting nailing

OTHER

For patients in the Titanium Elasting Nailing group, the nail applied retrogradely in femoral shaft fracture

Procedure: titanium elastic nailing

Interventions

titanium elastic nailingPROCEDURE

we inserted titanium nail in femoral fractures retrogradely

Also known as: TEN
titanium elasting nailing
Hip spica castingDEVICE

we applied cast for three weeks in patients with femoral shaft fracture

Also known as: TEN
hip spica casting

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • Segmental, Winquist type III and IV comminuted fractures, previously diagnosed neuromuscular disease (e.g., cerebral palsy), metabolic bone disorders (e.g. osteomalacia), or pathological fractures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-zahra university hospital

Isfahan, Isfahan, Iran

Location

Study Officials

  • hamidreza shemshaki, MD

    MD,research comittee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2010

First Posted

August 30, 2010

Study Start

February 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 30, 2010

Record last verified: 2009-02

Locations

IR(1)